Enhancement of Emmetropization in Hyperopic Infants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.
研究概览
简要总结
To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.
详细描述
The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Weeks 至 20 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 months of age (between 8 weeks and 20 weeks)at the baseline examination
- •Either gender, any ethnicity
- •Birthweight greater than 2500g
- •Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella)
- •Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
- •Currently under the care of a pediatrician
排除标准
- •Anisometropia greater than 1.00D (difference in spherical equivalent)
- •Strabismus
- •Previous history of difficulty with pupillary dilation
- •History of cardiac, liver, asthma, or other respiratory disease
- •History of ocular disease or active ocular inflammation
结局指标
主要结局
The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.
时间窗: 15 months
次要结局
未报告次要终点
研究者
Donald Mutti
Professor
Ohio State University